Clinical trial · Interventional
Neuroprotection of Memantine and Rosuvastatin
Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
NCT07504198CI-TRIAL-00106869not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Memantine is used to slow the neurotoxicity of Alzheimer disease. Rosuvastatin used as a lipid-lowering agent . Increased bioavailability of endothelial-derived nitric oxide improves endothelium function , increases cerebral blood flow which may all contribute to the neuroprotective effects of rosuvastatin . The goal of this clinical trial is to prevent oxaliplatin induced peripheral neuropathy in patients with colorectal cancer.The aim of this current study is to assess the neuroprotective effect of memantine and rosuvastatin against oxaliplatin induced peripheral neuropathy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Nerve Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Memantine | Drug | — | UNRESOLVED |
| Rosuvastatin 20 Mg Oral Tablet | Drug | — | UNRESOLVED |
| Starch Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Standard group
- description
- Patients will receive modified FOLFOX-6 regimen or XELOX regimen The chemotherapy cycles will be received every 14 days for modified FOLFOX-6 regimen or every 21 days for XELOX regimen for 6 months and will be as follows :modified FOLFOX regimen , oxaliplatin 85 mg/m2 intravenous infusion in 500 mL 5% dextrose solution(on days 1 and 15) and leucovorin 400 mg/m2 intravenous infusion in 250 mL 5% dextrose solution both were given over 2 hours at the same time in separate bags using a Y-line access , followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 5 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion. XELOX regimen , oxaliplatin 130 mg/m2 intravenous infusion in 500 mL 5% dextrose over 2 hours and capecitabine 850 mg/m2 or 1000 mg/m2 per dose twice daily (total dose 1700 or 2000 per day )from evening of day 1 to morning of day15 plus starch placebo orally
- interventionNames
- Drug: Starch Placebo
- type
- ACTIVE_COMPARATOR
- label
- Intervention group
- description
- patients with colorectal cancer will receive modified FOLFOX-6 regimen or XELOX regimen throughout the chemotherapy cycles plus memantine oral tablet 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day and rosuvastatin tablet 20 mg orally daily.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Age above 18 years old for both gender . * Adequate baseline hematologic values (absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance ˃ 45 mL/min). * Patients with adequate liver function (serum bilirubin \< 1.5 mg/dl). * Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score. * Patients who will be scheduled to receive modified FOLFOX-6 or XELOX regimen. * Patients with histologically confirmed diagnosis of stage III or stage IV colorectal cancer. Exclusion criteria: * Children \< 18 years old. * Prior exposure to neurotoxic chemotherapy (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH). * Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C. * History of known allergy to oxaliplatin or other platinum agents. * Patients with other inflammatory or stressful conditions. * Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin). * Patients on amantadine , acetazolamide, dextromethorphan, aluminum hydroxide magnesium hydroxide and febuxostat . * Concurrent active cancer originating from a primary site other than colon or rectum. * Pregnant and breastfeeding women. * Sever renal insufficiency (creatinine clearance \< 25 ml/ minute) .
References
Publications (3)
- BACKGROUNDMa G, Liu C, Hashim J, Conley G, Morriss N, Meehan WP, Qiu J, Mannix R. Memantine Mitigates Oligodendrocyte Damage after Repetitive Mild Traumatic Brain Injury. Neuroscience. 2019 Nov 21;421:152-161. doi: 10.1016/j.neuroscience.2019.10.016. Epub 2019 Nov 1. PMID 31682950
- BACKGROUNDWei G, Gu Z, Gu J, Yu J, Huang X, Qin F, Li L, Ding R, Huo J. Platinum accumulation in oxaliplatin-induced peripheral neuropathy. J Peripher Nerv Syst. 2021 Mar;26(1):35-42. doi: 10.1111/jns.12432. Epub 2021 Jan 27. PMID 33462873
- BACKGROUNDZisiadis GA, Alevyzaki A, Nicola E, Rodrigues CFD, Blomgren K, Osman AM. Memantine increases the dendritic complexity of hippocampal young neurons in the juvenile brain after cranial irradiation. Front Oncol. 2023 Oct 4;13:1202200. doi: 10.3389/fonc.2023.1202200. eCollection 2023. PMID 37860190